1. Field of the Invention
Hepatitis is a viral disease which can exist in both infectious and non-infectious form. It is of particular concern because of its transmission through blood transfusions. It is known that there are many carriers of the virus which are not subject to the symptoms of the disease. Nevertheless, these people are able to transmit the disease to others who are susceptible to infection, particularly through blood transfusions, where the blood is not carefully monitored.
Because of the widespread character of hepatitis, it would be desirable to be able to vaccinate people for the disease. For the most part, vaccines have relied upon the protein coat of the virus, which is only difficultly attainable and must be carefully purified to avoid any inclusion of the viral chromosome. Because of the expensive nature of the isolation and purification of the protein coat, an inexpensive vaccine has not been available which could be used, particularly in those areas which are unable to afford the high cost of the presently available vaccines.
2. Description of the Prior Art
Human serum albumin and the hepatitis B surface antigen are associated with the viral coat protein of the hepatitis B virus. Neurath et al. (1974) PNAS USA 71:2663; Ionescu-Matiu et al. (1980) J. Med. Virol. 6:175; Tiollais et al. (1981) Science 213:406. Thus, common occurrence of albumin molecules in the coat protein of viruses replicating in the liver is naturally expected. In vitro aging or heat or glutaraldehyde polymerization of albumin results in a product which elicits antibodies in immunized animals. Onica et al. (1980) Mol. Immunol. 17, 783. Antibodies to polymerized albumin have also been encountered in the sera of patients with acute or chronic liver disease. Lenkei et al. (1977) J. Med. Virol. 1, 29. Physiological and pathological production of antibodies to polymerized human albumin (PHALB) have been studied by Onica and Lenkei (Onica et al (1978) Immunochemistry 15, 941; Lenkei and Ghetie (1977) J. Immunol. Methods 16, 23 and Imai et al. (1979) Gastroenterology 76, 242. The interaction of PHALB with Clq and the relationship of serologic reactivity with PHALB in sera from patients with and without liver disease have been reported be Milich et al. (1980) Gastroenterology 79, 1116, and Milich et al (1981) Gastroenterology 81, 218.